Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

NCT07830719 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CYMI024A12202U1111-1339-3893
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; elevated hsCRP; inflammatory marker reduction

Outcome Measures

Primary Outcomes (1)

• Change from baseline in log-transformed IL-6

  Change from baseline in log-transformed Interleukin-6 (IL-6) to evaluate the dose-response relationship using the Multiple Comparison Procedures (MCP) component of the Multiple Comparison Procedure-Modelling (MCP-Mod) methodology

  Baseline and approximately 3 months

Secondary Outcomes (5)

• Change from baseline in log-transformed IL-6

  Baseline and approximately 3 months

• Change from baseline in log-transformed hsCRP

  Baseline and approximately 3 months

• Responder status - hsCRP <2 mg/L

  Approximately 3 months

• Responder status - hsCRP <1 mg/L

  Approximately 3 months

• Number of participants with adverse events

  Approximately 4 months

Study Arms (6)

YMI024 Dose 1

EXPERIMENTAL

Participants receive YMI024 Dose 1 in addition to standard-of-care therapies.

Drug: YMI024

YMI024 Dose 2

EXPERIMENTAL

Participants receive YMI024 Dose 2 in addition to standard-of-care therapies.

Drug: YMI024

YMI024 Dose 3

EXPERIMENTAL

Participants receive YMI024 Dose 3 in addition to standard-of-care therapies.

Drug: YMI024

YMI024 Dose 4

EXPERIMENTAL

Participants receive YMI024 Dose 4 in addition to standard-of-care therapies.

Drug: YMI024

YMI024 Dose 5

EXPERIMENTAL

Participants receive YMI024 Dose 5 in addition to standard-of-care therapies.

Drug: YMI024

Placebo

PLACEBO COMPARATOR

Participants receive a matching placebo in addition to standard-of-care therapies

Drug: Placebo

Interventions

YMI024 DRUG

YMI024 in different doses

YMI024 Dose 1; YMI024 Dose 2; YMI024 Dose 3; YMI024 Dose 4; YMI024 Dose 5

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to any study specific procedures, and participant able to understand and comply with study requirements.
• Male and female participants aged between 18-80 years (inclusive) at Screening.
• Documented stable CAD as evidenced by presence of at least one of the following criteria:
• Documented history of spontaneous (Type 1) myocardial infarction (MI) of presumed atherosclerotic origin that occurred at least 30 days before the start of Screening. If a Pre-screening visit is conducted, the MI must have occurred at least 30 days before that visit.
• Diagnosis of the qualifying MI should be based on medical records and Investigator's judgment.
• Prior coronary revascularization (i.e. percutaneous coronary intervention (PCI) at least 30 days prior, or coronary artery bypass grafting (CABG), at least 6 months prior to Screening).
• Any prior PCI must have occurred at least 30 days prior to the Screening Visit (or if conducted, prior to the Pre screening visit).
• Any prior CABG must have occurred at least 6 months (i.e. 26 weeks) prior to the Screening (or if conducted, prior to the Pre-screening) Visit.
• Angiographic or CT-imaging (e.g., Multi Detector Computed Tomography/ Computed Tomography Angiography (MDCT/CTA)) evidence of coronary atherosclerosis: ≥50% stenosis in at least one major epicardial coronary artery.
• Coronary artery calcium (CAC) score of ≥300 AU by computed tomography.
• To ensure adequate representation of patients with clinically relevant comorbidities and to enable prespecified subgroup analyses, the trial will include participants with key comorbidities as follows:
• i. Moderate CKD Participants with moderate (Stage 3a/3b) kidney disease (CKD) defined as: Estimated Glomerular Filtration Rate (eGFR) ≥30 and ≤60 mL/min/1.73 m² (CKD EPI formula) at Screening.
• ii. Chronic HF
• Participants with a history of chronic heart failure (HF) defined as:
• NYHA Class II-III symptoms of HF requiring ongoing treatment with diuretics (loop diuretics, thiazide diuretics, and/or mineralocorticoid receptor antagonists) for ≥30 days prior to Screening, AND

You may not qualify if:

• Participants with recent major cardiovascular events or procedures, including:
• myocardial infarction, unstable angina, or percutaneous coronary intervention within 30 days prior to Screening (or Pre-screening, if conducted), or
• coronary artery bypass grafting or other cardiac surgery within 6 months prior to Screening (or Pre-screening, if conducted).
• Any major (cardiac or non-cardiac) surgical, interventional or endoscopic procedure (e.g: Percutaneous carotid intervention, carotid or peripheral arterial revascularization), or stroke, Transient ischemic attack (TIA), or acute limb ischemia within 12 weeks prior to Screening or Pre-screening, where applicable).
• Participants with a known systemic autoimmune or inflammatory disease (e.g., Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)); clinically active diverticulitis or inflammatory bowel disease within 12 months prior to Screening; or a history of gastrointestinal perforation.
• Patients with suspected or proven immunocompromised state at Screening (e.g., clinical diagnosis of Human Immunodeficiency Virus (HIV) or on antiretroviral therapy, absolute neutrophil count ≤1000/mm3) or any other medical condition in the opinion of the Investigator places the patient at unacceptable risk by receiving immunomodulatory therapy.
• Known or suspected active infection, or chronic or recurrent infectious disease, including but not limited to:
• Hepatitis B / Hepatitis C: Positive HBsAg, positive anti-HBc, positive anti-HBs, or positive anti-Hepatitis C Virus (HCV) at Screening.
• Note: Participants positive for anti-HBs after HBV vaccination but negative for HBsAg and anti-HBc are eligible per local guidelines and Sponsor agreement.
• Note: Participants positive for anti-HBc but negative for HBV Deoxyribonucleic Acid (DNA) receiving prophylactic HBV antiviral treatment (e.g., entecavir, lamivudine) are eligible per local guidelines and Sponsor agreement.
• Note: Participants positive for anti-HCV but consistently negative for HCV RNA \>6 months after HCV antiviral treatment are eligible per local guidelines and Sponsor agreement.
• Tuberculosis (TB): Active or latent TB as indicated by a positive QuantiFERON® TB Gold Plus test or T-SPOT® TB test at Screening.
• Any other known active or suspected active infection, or chronic infection, or history of ongoing, chronic, or major recurrent infectious disease.
• Participants with any of the following renal or hepatic abnormalities at Screening are excluded:
• Renal dysfunction with Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m² (using CKD-EPI formula; s://.kidney.org/professionals/gfr\_calculator).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): October 19, 2027
• Study Completion (Estimated): October 19, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)